Hyperspectral Assessment & Prediction of Diabetic Foot U

描述（由申请人提供）：足部疾病并发症严重影响1型糖尿病患者的生活。评估治疗效果的定量方法，或更好地，以确定组织的风险和防止初始溃疡形成将是非常有益的。HYPERMED的长期目标是通过开发足部高光谱成像（FHSI）作为基于相机的系统来减少足部溃疡和截肢的频率，以1）识别有溃疡风险的组织，2）评估现有溃疡并预测组织愈合的能力，3）监测治疗效果。 FHSI提供了一个二维图像，每个像素中固有的光谱数据反映了各种化学物质的存在和浓度，代表了组分的“梯度图”。我们的第二阶段目标是验证FHSI作为一种定量解剖学指标，用于评估1型糖尿病中足部溃疡的治疗进展，并识别未来溃疡的风险组织，以帮助预防。我们将在第一阶段原理证明数据和我们其他工作的基础上取得进展。具体目标是：1）建立升级的FHSI系统，用于4个备受推崇的糖尿病诊所，在统计学上有把握的研究中具有强大的1型患者数量，2）研究50名具有明显足部溃疡的1型患者6个月以上，以评估愈合或进展，3）在24个月的纵向研究中研究160名具有足部溃疡高风险的1型患者，旨在预测溃疡，4）开发将提供高光谱微血管指数的算法，所述高光谱微血管指数可用作组织活力和伤口愈合的生物标志物，并给出风险的空间定量; 5）验证使用临床结果测量进一步开发FHSI的优点，并将FHSI与现有方法进行比较（ABI，激光多普勒，TCPO 2），以确定FHSI在临床足部护理中的优势和局限性。我们与关节疾病医院，克利夫兰诊所，橄榄景加州大学洛杉矶分校医疗中心和贝斯以色列执事医疗中心的合作将非常有利于在本研究计划期间实现我们的特定目标。 FHSI以与解剖结构相关的易于解释的图片提供有关组织的代谢信息。这为溃疡风险和组织愈合的评估增加了一个新的维度，使医生能够比以前更早地将护理目标对准特定的风险区域。FHSI具有明显的潜力，成为一个具有成本效益，易于使用，交钥匙相机为基础的工具。如果成功，FHSI将实现两个健康人2010目标：“降低糖尿病患者足部溃疡的频率”和“降低糖尿病患者截肢率”。我们相信FHSI可以对糖尿病患者的生活质量产生积极影响，影响发病率和死亡率，降低整体医疗成本。

DESCRIPTION (provided by applicant): Foot disease complications seriously impact lives of people with Type 1 diabetes. A quantitative method to evaluate efficacy of therapy, or better, to define tissue at risk & prevent initial ulcer formation would be highly beneficial. HYPERMED'S long-term objective is to reduce frequency of foot ulcers & amputation by developing Foot HyperSpectral Imaging (FHSI) as a camera-based system to 1) identify tissue at risk for ulceration, 2) evaluate an existing ulcer & predict capability of tissue to heal & 3) monitor efficacy of therapy. FHSI provides a 2-D image with spectral data inherent in each pixel which reflects the presence & concentration of various chemical species that represents a "gradient map" of components. Our Phase II goal is to validate FHSI as a quantitative anatomic metric for assessing therapeutic progress of foot ulcers seen in Type 1 diabetes & identify tissue at risk for future ulceration to assist in prevention. We will build on advances from proof of principle Phase I data & on our other work. Specific aims are to: 1)build upgraded FHSI systems for use at 4 well-respected diabetic clinics with strong Type 1 patient volume in statistically- powered studies, 2)study 50 Type 1 patients with manifest foot ulcers for 6+ months to assess healing or progression, 3)study 160 Type 1 patients at high risk for foot ulceration in a 24-month longitudinal study aimed at predicting ulceration, 4)develop algorithms that will deliver a Hyperspectral Microvascular Index that can be used as a biomarker for tissue viability & wound healing & give a spatial quantitation of risk & 5)validate merit in further developing FHSI using clinical outcome measures & comparing FHSI with existing methods (ABI, laser Doppler, TCPO2) to determine advantages & limitations of FHSI in clinical foot care. Our collaborative effort with the Hospital for Joint Disease, the Cleveland Clinic, Olive View UCLA Medical Center, and the Beth-Israel Deaconness medical centers will be highly advantageous in meeting our specific aims during this research program. FHSI delivers metabolic information about tissue in an easily interpretable picture that correlates with anatomy. This adds a new dimension to assessment of ulceration risk & tissue healing & allows physicians to target care to specific at risk areas earlier than previously possible. FHSI has clear potential to be a cost effective, easy to use, turn-key camera based tool. If successful, FHSI will address two Healthy People 2010 goals: "Reduce the frequency of foot ulcers in persons with diabetes" & "Reduce the rate of amputations in persons with diabetes". We believe FHSI can have positive impact on quality of life of people with diabetes, impacting morbidity & mortality & lowering overall healthcare costs.